Quality Assurance Specialist for a human tissue recovery organization. Responsibilities include technical writing, developing and implementing standard operating procedures and work instructions. Executing Good Tissue Practice (GTP) documentation review and supporting the Quality Assurance department.  Monitor processes and procedures to ensure compliance with applicable regulatory and industry standards, identify areas for continuous improvement and present solutions.

Quality Assurance Specialist Responsibilities:

• Develop and implement standard operating procedures and work instructions
• Review quality assurance records for completeness, accuracy, and compliance
• Conduct audits and generate reports
• Investigate deviations and perform root cause analysis using methodologies, such as: fishbone, 5 whys, comparative analysis, etc. Implement corrective actions
• Work cross-functionally with Operations and Medical Records in meeting deliverables in a compliant and efficient manner

Skills & Technical Expertise:

• Excellent data collection, analysis skills, strong attention to detail and technical writing skills
• Able to work in a team setting and independently under minimum supervision
• Strong technical and quality background related to biologics, knowledgeable in GTP or GMP FDA regulations relating to biologics is preferred
• Ability to read, analyze, and interpret government regulations, professional journals, research papers, and company policies
• Familiarity with electronic systems, including developing and producing reports using Microsoft Office
• Requires the ability to produce results in a fast-paced changing environment to meet deadlines
• Excellent communication skills, both verbal and written

Education & Previous Experience:

• Minimum of a B.S. Degree, Life Sciences discipline preferred
• +2 years’ experience in Quality Assurance/Quality Control function
• Working knowledge of tools, methods, and concepts of quality assurance
• CTBS is a plus